BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20343161 · Received October 1, 2024

    Report

    Report Number
    3003442380-2024-25631
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    August 18, 2024
    Report Date
    September 10, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018303
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2002749, DEVICE 10 OF 12.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON (B)(6) 2024 TWELVE INFUSION SET CANNULA WERE KINKED AND PATIENT FACES SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION IS ABDOMEN AND INFUSION SET ARE LONG FOR 4 HOURS. THE BLOOD GLUCOSE LEVEL IS HIGH, AND PATIENT IS ADDRESSING ISSUE DUE TO CORRECTION BOLUS VIA PUMP. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39966 AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002823 6007122 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female